Headquartered in Laguna Beach, Calif., privately held Advanced Cardiac Therapeutics,Inc. specializes in advanced irrigated cardiac catheter ablation systems with proprietary temperature-sensing technology for the treatment of patients with cardiac arrhythmias.
The company recently announced that the first patients have been enrolled in a first-in-man CE Mark clinical trial of the safety and performance of the company’s TEMPASURE cardiac ablation catheter.
Cardiac arrhythmias occur when the electrical impulses in the heart don’t work properly, causing the heart to beat too fast, too slowly or irregularly. Atrial fibrillation and atrial flutter are fast cardiac arrhythmias that can be life-threatening. Cardiac catheter ablation procedures are used to treat a variety of cardiac arrhythmias including atrial fibrillation and atrial flutter. The procedures involve advancing a catheter into the heart and selectively ablating certain areas of tissue in order to prevent the spread of electrical signals that give rise to the arrhythmia. The temperature of the tissue ablation is critical – lower temperatures are ineffective, and temperatures that are too high can result in dangerous over-heating. Saline irrigation ensures that lesions are created safely and are effective deeper inside the cardiac tissue. However, the inclusion of irrigation negates the effectiveness of conventional thermometry.
ACT’s technology enables, for the first time, measurement of tissue temperature with a saline-irrigated RF catheter. The TEMPASURE cardiac ablation catheter continuously measures temperature at three millimeters depth below the heart wall surface using VERITAS Technology, a proprietary microwave radiometry system. The TEMPASURE system is designed to improve patient outcomes by providing electrophysiologists with real-time validation information and greater control in lesion creation.
“Many years ago, the addition of a thermocouple enabled precise temperature control and temperature mode energy delivery to standard RF catheters. In a similar way, this microwave radiometry technology promises to significantly advance the way we perform irrigated RF ablations for patients with cardiac arrhythmias,” said Pedro Brugada, M.D., professor of Cardiology, chairman and scientific director, Cardiovascular Division, Brussels, Belgium, the study’s co-principal investigator.
“The initiation of our first-in-man study marks a major milestone for ACT,” said Peter van der Sluis, the company’s CEO. “We are very excited to soon launch the TEMPASURE temperature-sensing ablation catheter.”
Kenneth Carr, Dr. Eng. who pioneered microwave radiometry technology, commented, “It is incredibly exciting to see my life’s work proceed to clinical use and directly benefit patients with cardiac arrhythmias.”
Advanced Cardiac Therapeutics will present their technology at OneMedForum NY 2011 June 22-24.